Effectiveness of the Pilates Method Versus Aerobic Exercises in the Treatment of Chronic Non-specific Low Back Pain in the Elderly: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. However, the evidence about the effectiveness of Pilates method in the treatment of elderly patients with low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. This randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. Secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. We expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly complaining of non-specific low back pain for more than three months
- •Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.
排除标准
- •Contraindication to physical exercise;
- •Back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests);
- •Previous or scheduled back surgery ;
- •Severe cardiorespiratory disease;
- •Cognitive impairment;
- •Dependent gait;
- •Patients who underwent physical therapy for low back pain in the last six months;
- •Regular physical activity practitioners.
结局指标
主要结局
Pain intensity
时间窗: Eight weeks after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disabitity
时间窗: Eight weeks after randomization
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
次要结局
- Disability(Six months after randomization)
- Global impression of improvement(Eight weeks and six months after randomization)
- Specific disability(Eight weeks and six months after randomization)
- Dynamic balance(Eight weeks and six months after randomization)
- Dynamic Balance(Eight weeks and six months after randomization)
- Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators(Eight weeks and six months after randomization)
- Pressure pain threshold(Eight weeks and six months after randomization)
- Pain intensity(Six months after randomization)
研究者
Cristina Maria Nunes Cabral
PhD
Universidade Cidade de Sao Paulo